Fremont, CA

Job Description

Staff Scientist-Operations-Freemont, CA


  • Ensure production goals are achieved and assure production and laboratory standards are in compliance with all GMP, ISO, FDA, OSHA and other company manufacturing and safety guidelines.
  • Responsible for scheduling for TDM manufacturing and tracking on status for manufacturing work orders. Direct the product line operations to achieve on time delivery, demand-based capacity throughput, safety, quality, cost and continuous improvement through lean leadership.
  • Provide leadership to accomplish continuous improvement in quality, manufacturing cycle time and total cost by advocating and driving the PPI Business System within the operations.
  • Manufacture advanced products (as needed) and complete batch records following cGMPs
  • Perform in-process assays using clinical analyzers. Review and analyze data.
  • Maintain and analyze lot histories for trends and discrepancies
  • Review and approve completed batch records.
  • Write, review, and modify SOPs, work instructions and reports.
  • Initiate and complete DCO and Change Control
  • Write, review, and execute process validations as appropriate. Support and contribute to projects.
  • Technical expert for all products and serve as a technical resource for team. Initiate, evaluate, and support investigations for NCARs, CAPAs, and VARs and coordinate with product support team for technical issues.
  • Train team on equipment/procedures/processes
  • Keep manager updated on all issues.
  • Address roadblocks for the team.
  • Lead 6S and other process improvement efforts
  • Perform other job duties as required.

 Minimum Requirements/Qualifications:

  • B.S. degree in life scientific discipline (biology/biochemistry) or other scientific/technical discipline required.
  • A minimum of 5 years of industry related experience with expertise in leading the team and developing staff in a manufacturing and/or distribution operations environment.
  • Advance lab skills and knowledge of safety precautions.
  • Knowledge of Quality System Regulations.
  • Experienced with Variance, NCAR, CAPA, and Validation/Qualification
  • Extensive previous experience in immunohistochemistry, diagnostic manufacturing environment with through knowledge of a variety of laboratory chemicals, potentially hazardous chemicals, human source materials, and reagent manufacturing activities.
  • Experience in implementing or working with an effective continuous improvement i.e. LEAN, Six Sigma, etc
  • Technical skills in manufacturing techniques, FDA, GMP, ISO 13485 compliance, process improvement and process development.
  • Practical understanding and experience with IT systems (ERP, MES, WMS etc.)
  • Ability to lead, motivate and influence others.
  • Excellent communication, executive presentation, and leadership skills with a collaborative approach to problem solving
  • Collaboration skills – Able to effectively collaborate with peers in other operations and with colleagues in other departments.
Responsible for leading the TDM production team with scheduling and tracking on status for manufacturing work orders. Support and contribute to the projects including transfer of new products into manufacturing and process improvement. Review and completes production batch record and associated documentation. Support the technical investigation and collaborate with product support team.
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